Using Implementation Science to Address TB/HIV Co-Infection in ...

Implementation Science: Evidence to Action

Wafaa El-Sadr, MD, MPH, MPA ICAP at Columbia University

Outline

• Achievements and challenges in HIV response

• Knowledge-impact gap (Know-do gap)

• Research pathway

• Implementation science

• ICAP and implementation science

• Summary and conclusions

HIV Treatment Coverage and AIDS-related Deaths, global, 2000–2015

Reaching the Third 90: Implementing High Quality VL Monitoring at Scale – Ezulwini,

Swaziland, June 27-30, 2016 3

New WHO Treatment Guidelines

New WHO guidelines

recommend HIV

treatment for all

4

HIV Treatment: Global Targets By 2020

90%

of all people living with HIV will know their

HIV status

90%

of all people diagnosed with HIV will receive

sustained antiretroviral

therapy

90%

of all people receiving

antiretroviral therapy will have

durable suppression

UNAIDS 2014

5

HIV Continuum

Continuum of HIV Care

80

62

41 37

28

40

24 16

11

0

10

20

30

40

50

60

70

80

90

100

HIV Positive Diagnosed Linked toCare

Retained/Initiated

Retained onART

VirusSuppressed

US SubSaharan Africa

NA

Challenges in HIV Care Continuum

Critical Issues

• How to define the target population?

• How to reach and engage the target population?

• How to adapt intervention(s) to specific contexts?

• How to deliver and package the intervention(s)?

• Why did intervention(s) work/not work?

• What is acceptability, feasibility and cost-effectiveness of intervention(s)?

• Etc. etc.

Initial research often involves populations, procedures and settings that differ substantially from the context of

implementation

Knowledge to Impact Gap

Knowledge • Efficacious interventions • Often demonstrated

through randomized clinical trials

• High level of internal validity

Implementation • Engaged communities and

target populations • Infrastructure • Equipment & Supplies • Staff • Policies • Processes

Sanders et al, PLoS Medicine, 2006

Explanatory versus Pragmatic Research

Explanatory Research

• Descriptive and epidemiologic research

– What, why, where, who?

• Intervention research

– What?

Pragmatic Research

• How to translate knowledge into practice within health and social systems

Eccles et al. Implementation Science, 2012 Sanders et al, PLoS Medicine, 2006 El-Sadr et al. NEJM 2014

Research Pathway

https://www.brown.edu/about/administration/biomed/clinical-translational-science/index.php?q=about/translational-research

What is Implementation Science? • ‘Research to promote the uptake & successful implementation of

evidence-based interventions and policies’ (Sanders)

• ‘Evidence that informs effective, sustained & embedded adoption of interventions by health systems & communities’ (Allottey)

• ‘All aspects of research relevant to the scientific study of methods to promote the uptake of research findings into routine settings in clinical, community and policy contexts’

• ‘Research to significantly improve access to efficacious interventions by developing practical solutions to common implementation problems’ (WHO)

• ‘Study of how to accelerate the translation of research-tested interventions into policy and practice’ (Best)

• 'Implementation Research is the scientific study of methods to promote the systematic uptake of clinical research findings and other evidence-based practices into routine practice, and hence to improve the quality (effectiveness, reliability, safety, appropriateness, equity, efficiency) of health care. It includes the study of influences on healthcare professional and organizational behaviour.'

Sanders et al, PLOS Med, 3:e186; Allottey et al, BMC Pub Health 8:343, WHO;, Best Am J Health Promot 2011 Adapted: http://www.implementationscience.com/info/about/ accessed 10 February 2009

Factors affecting Implementation of health innovations

Chaudoir et al. Implementation Science 2013

Characteristics of Implementation Science

• Systematic

• Multi/interdisciplinary

• Contextual

• Complex

Characteristics of Implementation Research

• Systematic – Adheres to norms of scientific inquiry

– Specific intervention, specific setting

– Balances relevance with rigor

• Multi/Interdisciplinary – Considers biological, social, economic, political,

system and environmental factors that impact implementation

– Collaborations between behavioral and social scientists, clinicians, epidemiologists, statisticians, policy makers, stakeholders

Characteristics of Implementation Research (continued)

• Contextual – Relevant to local circumstances and need

– Generates generalizable knowledge that can be applied across contexts

• Complex – Dynamic and adaptive

– Occurs at multiple levels of health care system, community

– Analyzes multi-component programs

ICAP and Implementation Science

Where ICAP Works

Implementation Science Studies

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

HIV infected DiagnosedHIV

Linked toCare

Retained inCare

Initiated ART Viral LoadSuppression

Assessed for ART

eligibility

Retained in care

Link4Health: Intervention Combination Intervention Strategy (CIS)

23

Cas

cad

e

Ste

p

Linked to Care

Assessed for ART

Eligibility

Initiated ART

Retained in Care

CIS

Co

mp

on

ents

1. Point-of-care CD4 at HIV testing X X X

2. Accelerated ART for CD4 < 350 X X

3. SMS appointment reminders X X

4. Basic care and prevention package X X

5. Non-cash financial incentive X X

Link4Health: Study Design

• Cluster-randomized controlled trial – 10 study units randomized to CIS versus

Standard of Care

– Study unit included 1 secondary and 1 affiliated primary-level health clinic

• Study population: – > 18 years identified as HIV+

Primary outcome: Linkage: HIV clinic visit within 1 month after HIV testing at assigned study unit

and

Retention: HIV clinic visit within 12 months (+/- 3 months) after HIV testing at assigned study unit

24

Pragmatic Design (PRECIS-2)

Loudon et al. BMJ 2015

*

*

*

Mapping of Studies

Thorpe et al. J of Clin Epi, 2009

Link4Health Study

Loudon et al. BMJ 2015

*

*

*

Approach to the Research

• Conduct of feasibility assessments with the target population and consultation with program managers and policy makers

• Interdisciplinary engagement

• Research done by facility staff rather research staff

• Selection of standard program outcomes as research outcomes

Approach to the Research- 2

• Measuring the research outcome through routinely-collected data

• Adaptation of intervention(s) without loosing fidelity to the core of the efficacious interventions being studied

• Capturing why and how interventions work/don’t work rather than solely focusing on if they work/don’t work

Summary

• Many implementation gaps that stand in the way

of achieving impact of efficacious interventions

• Implementation science critical to advancing

population health

• Rigorous and pragmatic research designs are

needed that adhere to the principles and

framework of implementation science

• Need for focus on why interventions work/don’t

work in addition to if they work

• Partnership between researchers,

implementation experts and other stakeholders

is critical to the success of research

Thank you Asante Sana